China Plant Sterol Trial

This study has been completed.
Sponsor:
Collaborator:
Peking University
Information provided by:
The George Institute
ClinicalTrials.gov Identifier:
NCT00145717
First received: September 2, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The aim of this study is to see if plant sterols are effective at lowering blood cholesterol levels in Chinese people. The study will be done with Chinese colleagues based at Peking University in Beijing with whom our Institute has a well-established collaboration. The study will be randomised, placebo-controlled and double-blind. The total study period for participants will be an average of seven weeks comprised of a two-week placebo run-in period and a five-week follow-up on randomised treatment. Randomised treatment will comprise either placebo, low- or standard-dose plant sterol. The primary outcome for the study will be blood cholesterol levels.


Condition Intervention Phase
Hypercholesterolemia
Cardiovascular Diseases
Drug: Plant sterol enriched milk tea
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: China Plant Sterol Trial – A Randomised Trial to Determine the Effects on Blood Cholesterol Levels of a Milk Tea Product Enriched With Plant Sterol Among 300 Chinese Living in Beijing

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Low density lipoprotein cholesterol levels

Secondary Outcome Measures:
  • Total cholesterol levels;
  • High density lipoprotein cholesterol levels;
  • Triglycerides levels;
  • Liking and adherence

Estimated Enrollment: 300
Study Start Date: April 2005
Estimated Study Completion Date: July 2005
Detailed Description:

RESEARCH PLAN The study is a randomised, double-blind, placebo-controlled trial with three parallel groups, two assigned different doses of active treatment and one assigned placebo. The total study period for participants will be an average of seven weeks comprised of a two-week placebo treatment run-in period prior to randomisation and a five-week follow-up on randomised treatment. An estimated 400 participants will be commenced on run-in with the expectation that 300 (100 in each group) will go on to randomisation.

STUDY TREATMENTS Pre-randomisation open run-in phase: All potentially eligible participants will commence a 10-20 days run-in period with the placebo milk tea administered twice daily. This run-in period will help to identify before randomisation, those individuals who are unlikely to tolerate the milk tea product or comply with the study follow up procedures.

Post randomisation double-blind treatment phase: Participants that successfully complete the run-in phase will be assigned at random to receive either:

  • Milk tea containing a total of 2.3g of plant sterol each day administered in two divided doses of 1.15g; or
  • Milk tea containing a total of 1.5g of plant sterol each day administered in two divided doses of 0.75g; or
  • Placebo milk tea containing no plant sterol. Blinding of participants and investigators will be assured by providing all groups with their allocated treatment in packaging that is identical except for a unique identifying number corresponding to the randomisation code.

Comparisions:

  • 2.3g/d treatment group compared to placebo group
  • 1.5g/d treatment group compared to placebo group
  • active treatment group (2.3g/d and 1.5g/d combined) compared to placebo group
  • 2.3g/d treatment group compared to 1.5g/d treatment group
  • Secondary: To establish the effects of the same intervention on total cholesterol levels.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The key inclusion criteria will be:

  • Age between 18 and 65 years old (inclusive) at baseline
  • Able to provide informed consent
  • Usual diet that includes significant fat consumption at the main meals eaten each week and/or a history of hypercholesterolemia
  • Participant is likely to comply with the study treatment during the study period

Exclusion Criteria:

Participants will be excluded on the basis of:

  • Known serious gastrointestinal disease or other serious illness. Individuals with stable cardiovascular disease will, however, be eligible
  • Known lactose intolerance or diet that excludes dairy products
  • Known Sitosterolaemia (a very rare genetic condition causing very high blood sitosterol levels)
  • Current hospitalisation
  • Current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol (e.g. ezetimibe, bile acid-binding resins, or orlistat)
  • Participant is currently using or is planning to use non-trial plant sterol/stanol-containing products for the seven week study period
  • Participation in another study within last 3 months
  • Pregnant or planning to become pregnant in next three months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145717

Locations
China
Peking University Health Science Centre
Beijing, China, 100083
Sponsors and Collaborators
The George Institute
Peking University
Investigators
Principal Investigator: Bruce C Neal, MRCP, PhD The George Institute
  More Information

No publications provided by The George Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00145717     History of Changes
Other Study ID Numbers: CPST
Study First Received: September 2, 2005
Last Updated: September 2, 2005
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The George Institute:
Phytosterols
Cholesterol
China
Randomized controlled trial

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014